Phase III Study Comparing TQB2102 Injection to Trastuzumab Emtansine Injection for Treating HER2-positive Advanced Breast Cancer

What this Trial Is About

This trial studies patients with HER2-positive advanced breast cancer who have unresectable, locally advanced, or metastatic invasive breast cancer. Researchers are comparing two drug treatments, TQB2102 injection and trastuzumab emtansine injection, to evaluate their effects on progression-free survival. This is a randomized, open-label, phase III clinical trial designed to assess the efficacy and safety of these treatments in this patient population. Participants are randomly assigned to receive either TQB2102 or trastuzumab emtansine by intravenous infusion. TQB2102 is given at a dose of 6 mgkg every 3 weeks, while trastuzumab emtansine is given at 3.6 mgkg every 3 weeks. Each infusion cycle lasts 3 weeks, and treatment continues according to the protocol. The trial includes multiple centers and uses positive drug control design. During the study, participants will be monitored for progression-free survival assessed by an Independent Review Committee over 30 months. Additional evaluations include overall survival, duration and rate of response, clinical benefit rate, and safety assessments of adverse events. Antibody levels and immune responses will be measured at various cycles. Follow-up for survival outcomes may continue up to 5 years. Participants will have regular visits for assessments, safety monitoring, and laboratory tests throughout the trial duration.

Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer